NCT00733486终止4 期
A Prospective, Non-Comparative Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (AP Glide) Mobile Bearing Knee System in Primary Knee Arthroplasty
DePuy International3 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2005年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 233
- 试验地点
- 3
- 主要终点
- A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years.
研究概览
简要总结
The primary objective of this investigation is to determine the survivorship of the LCS Complete AP Glide mobile bearing knee prosthesis at 5 years.
The secondary objectives of this investigation are to evaluate the clinical performance of the LCS® Complete AP Glide mobile bearing knee prosthesis and to determine its long-term survivorship.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, aged between 45 and 85 years inclusive.
- •Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- •Subjects who present with any pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
- •Subjects who have an intact posterior cruciate ligament and well functioning medial and lateral collateral ligaments.
- •Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the LCS Complete AP Glide mobile bearing knee system, according to the indications specified in the package insert leaflet.
排除标准
- •Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- •Revision of an existing knee implant (including unicompartmental implants).
- •Female subjects who are pregnant.
- •Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- •Subjects who have participated in a clinical study with an investigational product in the last month (30 days).
- •Subjects who are currently involved in any personal injury litigation claims.
- •Subjects involved in personal Medical-Legal claims.
- •Subjects with a known history of poor compliance to medical treatment.
研究组 & 干预措施
L.C.S. APG Knee Anterior Posterior Glide knee
Other
Orthopaedic implant for primary knee replacement
干预措施: L.C.S. APG Knee Anterior Posterior Glide knee (Device)
结局指标
主要结局
A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years.
时间窗: 2 years
次要结局
- Assessment of component alignment and positioning(3 years post-operatively)
- Change from baseline to 3 year post-operative assessment in clinical outcome (stability, pain, range of motion and function) using the American Society Score(Pre-op to 3 years)
- Patient derived outcome in terms of general quality of life, as determined by the SF-12(3 years post-operatively)
- Assessment of radiolucencies(3 years post-operatively)
- Assessment of Patella Tilt and patellofemoral alignment(3 months, 1 yr, and 3 yrs)
- Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score(3 years post-operatively)
- Changes from baseline to 3 months post-operative assessment in:Clinical outcome (stability, pain, range of motion and function), using the American Knee Society Score.(Pre-op to 3 months)
- Change from baseline to 1 year post-operative assessment in clinical outcome (stability, pain, range of motion and function) using the American Society Score(Pre-op to 1 year)
- Incidence of anterior knee pain and patellar function using the Patellar Score(3 year post-operatively)
- A survival analysis of the LCS Complete AP Glide knee prosthesis(3 years post-operatively)
- Incidence of anterior knee pain and patellar function using the Patellar Score(3 months post-operatively)
- Incidence of anterior knee pain and patellar function using the Patellar Score(1 year post-operatively)
- Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score(3 months post-operatively)
- Assessment of radiolucencies(3 months post-operatively)
- Assessment of radiolucencies(1 year post-operatively)
- Assessment of component alignment and positioning(1 year post-operatively)
- Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score(1 year post-operatively)
- Patient derived outcome in terms of general quality of life, as determined by the SF-12(3 months post-operatively)
- Patient derived outcome in terms of general quality of life, as determined by the SF-12(1 year post-operatively)
- A survival analysis of the LCS Complete AP Glide knee prosthesis(1 year post-operatively)
- Assessment of component alignment and positioning(3 months post-operatively)
研究者
研究点 (3)
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